Operating an Infusion Pump System

ABSTRACT

Some embodiments of a medical infusion pump system include a pump device and a removable controller device. When the pump device and the removable controller device are removably attached to one another, the components may provide a portable infusion pump unit to dispense medicine to a user. In particular embodiments, the removable controller device includes a user interface to readily provide information, for example, about the operation of the pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/522,603 filed on Sep. 18, 2006 by Mark Estes et al., which claimspriority to: (1) U.S. Provisional Application Ser. No. 60/720,411 filedon Sep. 26, 2005 by Mernoe et al. and entitled “Precision DriveMechanism,” (2) U.S. Provisional Application Ser. No. 60/720,405 filedon Sep. 26, 2005 by Mernoe et al. and entitled “Flexible PushrodMechanism,” and (3) U.S. Provisional Application Ser. No. 60/721,267filed on Sep. 28, 2005 by Estes et al. and entitled “Infusion Pump withRemovable Controller.” The contents of these earlier applications arefully incorporated by reference herein.

TECHNICAL FIELD

This document relates to an infusion pump system, such as a medicalinfusion pump system.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

A number of factors may affect the design of infusion pump devices. Onesuch factor is the size of the device. The pump device may be sized tohouse the various pump components, yet a large device may reduce theportability for the user. Another factor that may affect the design ofan infusion pump device is the convenience to the user. For example, ifthe pump device is designed to be controlled via a user interface on alarge wireless module that must be separately carried, the user may notbe able to monitor the operation of the infusion pump during use withoutfirst locating, handling, and interfacing with the separate wirelessmodule. A number of infusion pump components can impact the overall sizeand portability of an infusion pump system and the convenience to theuser.

SUMMARY

Some embodiments of a medical infusion pump system include a pump deviceand a removable controller device. When the pump device and theremovable controller device are removably attached to one another, thecomponents may provide a portable infusion pump unit to dispensemedicine to a user. In particular embodiments, the removable controllerdevice includes a user interface to readily provide information, forexample, about the operation of the pump.

In some embodiments, a medical infusion pump system may include a pumpdevice having a drive system to dispense a medicine from the pumpdevice. At least a portion of the drive system may be in electricalcommunication with one or more electrical contacts of the pump device.The system may also include a removable controller device having a userinterface. The removable controller device may be removably attachableto the pump device in a fixed relationship. The controller device mayinclude one or more electrical contacts that engage the electricalcontacts of the pump device when removably attached.

Particular embodiments of a medical infusion pump system may include apump device having a drive system to dispense a medicine from the pumpdevice. The system may also include a first removable controller devicehaving a first user interface. The first removable controller device maybe mechanically attachable to the pump device and may be electricallyconnected to the pump device when mechanically attached. The system mayfurther include a second removable controller device having a seconduser interface that is different from the first user interface. Thesecond removable controller device may be mechanically attachable to thepump device and may electrically connected to the pump device whenmechanically attached. In certain aspects, the pump device may bemechanically attachable to only one of the first and second removablecontroller devices at a time.

Some embodiments of a medical infusion pump system may include a pumpdevice having a drive system to dispense a medicine from the pumpdevice. The pump device may include a first battery. The system may alsoinclude a removable controller device mechanically attachable to thepump device. The removable controller device may be electricallyconnected to the pump device when mechanically attached. The controllerdevice may include a second battery. The first battery may have agreater energy density than the second battery and may provide energy tocharge the second battery over a period of time. The second battery mayprovide energy to at least a portion of the drive system of the pumpdevice.

In certain embodiments, a medical infusion pump system includes a pumpdevice and a removable controller device. The pump device may include apump housing that defines a space to receive a medicine and a drivesystem to dispense the medicine when received by the pump housing. Thedrive system may include a piston rod that is incrementally movable toapply a dispensing force. The pump device may also include one or moreelectrical contacts disposed on the pump housing. At least a portion ofthe drive system may be in electrical communication with the one or moreof the electrical contacts. The removable controller device may includea controller housing that is removably attachable to the pump housing ina fixed relationship. The removable controller device may also includeone or more electrical contacts disposed on the controller housing. Theelectrical contacts of the controller device may be engageable with theelectrical contacts of the pump device when removably attached. Theremovable controller device may further include a user interfacearranged on the controller housing. The user interface may include adisplay and one or more user-selectable buttons. The pump device and thecontroller device, when removably attached, may provide a hand-graspableportable unit.

Some embodiments described herein may include a method for operating amedical infusion pump system. The method may include transmittingelectrical energy, from a first battery in a pump device to a secondbattery in a removable controller device. The pump device may include adrive system to dispense a medicine from the pump device, and theremovable controller device may be removably attached to andelectrically connected to the pump device. The method may also includeintermittently transmitting electrical energy from the second battery inthe removable controller device to at least a portion of the drivesystem of the pump device. The first battery may have a greater energydensity than the second battery and may provide energy to charge thesecond battery over a period of time.

These and other embodiments may provide one or more of the followingadvantages. First, the infusion pump system may be portable so that auser can wear the pump device (e.g., adhered to the user's skin orcarried in a user's pocket or portion of clothing) and receive theinfused medicine throughout the day or night. Second, the pump device ofthe infusion pump system may include a drive system that controllablydispenses medicine in a reliable manner. Third, the pump device of theinfusion pump system can be removably attached to a controller devicehaving a user interface. As such, the user can readily monitor theoperation of the pump device without the need for carrying and operatingan separate wireless module. Fourth, the infusion pump system maycomprise two or more removable controller devices having different userinterfaces. In these circumstances, a first controller device having afirst user interface can be selected for use with the pump device, or asecond controller device having a second user interface can be selectedfor use with the pump device. Fifth, the pump device may be capable ofdispensing a first medicine when connected with a first controllerdevice and may be capable of dispensing a second medicine when connectedwith a second controller device. Sixth, the pump device may include afirst battery that recharges a second battery in the controller device,which in turn provides power to the drive system of the pump. Thus, eachtime a new pump device is connected to the controller device, the secondbattery in the reusable controller device is recharged, thereby reducingor possibly eliminating the need for separate recharging of thecontroller device.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system, in accordancewith some embodiments.

FIG. 2 is another perspective view of the infusion pump system of FIG.1.

FIG. 3 is another perspective view of the infusion pump system of FIG.1.

FIG. 4 is a perspective view of an infusion pump system, in accordancewith some embodiments.

FIGS. 5A-D are examples of a user interface of a first controller devicein the infusion pump system of FIG. 4.

FIGS. 6A-D are examples of a user interface of a second controllerdevice in the infusion pump system of FIG. 4.

FIG. 7 is an exploded view of a pump device of the infusion pump systemof FIG. 4.

FIG. 8 is a perspective view of a controller device of the infusion pumpsystem of FIG. 4.

FIG. 9 is a perspective view of one controller device of the infusionpump system of FIG. 4.

FIG. 10 is a perspective view of another controller device of theinfusion pump system of FIG. 4.

FIG. 11 is an exploded view of a portion of the pump device of theinfusion pump system of FIG. 4.

FIGS. 12A-C are perspective views of a portion of the pump device ofFIG. 9.

FIG. 13 is a perspective view of a portion of a pump device for aninfusion pump system, in accordance with some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1-2, some embodiments of an infusion pump system 10include a pump device 100 that can communicate with a controller device200. The pump device 100 includes a housing structure 110 that defines acavity 116 in which a fluid cartridge 120 is received. In thisembodiment, the pump system 10 in a medical infusion pump system that isconfigured to controllably dispense a medicine from the cartridge 120.As such, the fluid cartridge 120 may contain a medicine to be infusedinto the tissue or vasculature of a targeted individual, such as a humanor animal patient. For example, the pump device 100 can be adapted toreceive a medicine cartridge 120 in the form of carpule that ispreloaded with insulin or another medicine for use in the treatment ofDiabetes (e.g., Byetta®, Symlin®, or others). Such a cartridge 120 maybe supplied, for example, by Eli Lilly and Co. of Indianapolis, Ind.Other examples of medicines contained in the fluid cartridge 120include: pain relief drugs, hormone therapy, blood pressure treatments,anti-emetics, osteoporosis treatments, or other injectable medicines.

In some embodiments, the controller device 200 may be removably attachedto pump device 100 so that the two components are mechanically mountedto one another in a fixed relationship. Such a mechanical mounting canreleasably secure an electrical connection between the removablecontroller device 200 and the pump device 100. For example, thecontroller device 200 may be in electrical communication with a portionof a drive system (not shown in FIGS. 1-2) of the pump device 100. Asdescribed in more detail below, the pump device 100 includes a drivesystem that causes controlled dispensation of the medicine or otherfluid from the cartridge 120. In some embodiments, the drive systemincrementally advances a piston rod (not shown in FIGS. 1-2)longitudinally into the cartridge 120 so that the fluid is force out ofthe output end 122. In this embodiment, the septum at the output end 122can be pierced to permit fluid outflow when a cap member 115 isconnected to the pump housing structure 110 (described in more detailbelow, for example, in connection with FIG. 5). Thus, when the pumpdevice 100 and the controller device 200 are removably attached andthereby electrically connected, the controller device 200 communicateselectronic control signals via hard-wire-connection to the drive systemor other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

Still referring to FIGS. 1-2, The controller device 200 can include acontroller housing structure 210 that is configured to mate with acomplementary portion of the pump housing structure 110 so as to form areleasable mechanical connection. For example, the controller housingstructure 210 may define a cavity (refer, for example, to FIG. 6) thatmates with a portion of the pump housing structure 110 for a snap fitengagement. Also, the controller housing structure 210 may include afinger 212 that engages a mating surface 117 of the pump housingstructure 110 when the controller device 200 is removably attached tothe pump device 100. As described in more detail below in connectionwith FIGS. 5-6, a magnetic attachment may be employed to releasablysecure the pump device 100. For example, the magnetic attachment canserve to retain the pump housing structure 110 in the cavity defined bythe controller housing structure 210. In alternative embodiments, one ormore releasable connector devices (e.g., mating tongues and grooves,mounting protrusions friction fit into mating cavities, or the like) canbe used to further implement the releasable securement of the controllerdevice 200 to the pump device 100.

As described in more detail below in connection with FIGS. 5-6, the pumpdevice 100 may include one or more electrical contacts (e.g., conductivepads, pins, and the like) that are exposed to the controller device 200and that mate with complementary electrical contacts on the adjacentface of the controller device 200. The electrical contacts provide theelectrical communication between the control circuitry of the controllerdevice 200 and at least a portion of the drive system or othercomponents of the pump device 100. For example, in some embodiments, theelectrical contacts permit the transmission of electrical controlsignals to the pump device 100 and the reception of feedback signals(e.g., sensor signals) from particular components within the pump device100.

Still referring to FIGS. 1-2, the controller device 200 includes a userinterface 220 that permits a user to monitor the operation of the pumpdevice 100. In some embodiments, the user interface includes a display222 and one or more user-selectable buttons (e.g., two buttons 224 a and224 b in this embodiment). The display 222 may include an active area223 in which numerals, text, symbols, images, or combination thereof canbe displayed. For example, the display 222 may be used to communicate anumber of settings or menu options for the infusion pump system 10. Inthis embodiment, the user may press one or more of the buttons 224 a and224 b to shuffle through a number of menus or program screens that showparticular settings and data (e.g., review data that shows the medicinedispensing rate, the total amount of medicine dispensed in a given timeperiod, the amount of medicine scheduled to be dispensed at a particulartime or date, the approximate amount of medicine remaining the cartridge120, or the like). As described in more detail below, in someembodiments, the user can adjust the settings or otherwise program thecontroller device 200 by pressing one or more buttons 224 a and 224 b ofthe user interface 220. In embodiments of the infusion pump system 10configured to dispense insulin, the user may press one or more of thebuttons 224 a and 224 b to change the dispensation rate of insulin or torequest that a bolus of insulin be dispensed immediately or at ascheduled, later time.

As shown in FIG. 1, the display 222 of the user interface 220 may beconfigured to display quick reference information when no buttons 24 aand 224 b have been pressed. In this example, the active area 223 of thedisplay 222 can display the time and the date for a period of time afterno button 224 a or 224 b has been actuated (e.g., five seconds, 10seconds, 30 seconds, 1 minute, 5 minutes, or the like). Thereafter, thedisplay 222 may enter sleep mode in which the active area 223 is blank,thereby conserving battery power. In addition or in the alternative, theactive area can display particular device settings, such as the currentdispensation rate or the total medicine dispensed, for a period of timeafter no button 224 a or 224 b has been actuated (e.g., five seconds, 10seconds, 30 seconds, 1 minute, 5 minutes, or the like). Again,thereafter the display 222 may enter sleep mode to conserve batterypower. In certain embodiments, the display 222 can dim after a firstperiod of time in which no button 224 a or 224 b has been actuated(e.g., after 15 seconds or the like), and then the display 22 can entersleep mode and become blank after a second period of time in which nobutton 224 a or 224 b has been actuated (e.g., after 30 seconds or thelike). Thus, the dimming of the display device 222 can alert a userviewing the display device 222 when the active area 223 of the displaydevice will soon become blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the user interface 220connected to the pump device 100. Such monitoring capabilities mayprovide comfort to a user who may have urgent questions about thecurrent operation of the pump device 100 (e.g., the user may be unableto receive immediate answers if wearing an infusion pump device havingno user interface attached thereto).

Also, there is no need for the user to carry and operate a separatemodule to monitor the operation of the infusion pump device 100, therebysimplifying the monitoring process and reducing the number of devicesthat must be carried by the user. If a need arises in which the userdesires to monitor the operation of the pump device 100 or to adjustsettings of the pump system 10 (e.g., to request a bolus amount ofmedicine), the user can readily operate the user interface 220 removablyattached to the pump device 100, without the requirement of locating andoperating a separate monitoring module.

It should be understood from the description herein that the userinterface 200 is not limited to the display and buttons depicted inFIG. 1. For example, in some embodiments, the user interface 220 mayinclude only one button or may include a greater numbers of buttons,such as three buttons, four buttons, five buttons, or more. In anotherexample, the user interface of the controller device 200 may includetouch screen so that a user may select buttons defined by the activearea of the touch screen display. Alternatively, the user interface maycomprise audio inputs or outputs so that a user can monitor theoperation of the pump device. Previously incorporated U.S. ProvisionalApplication Ser. No. 60/721,267 also describes a number ofconfigurations for a removable controller device and a user interfacefor the device in addition to the configuration illustrated in FIGS. 1-2herein.

Referring to FIG. 3, the infusion pump system 10 may be configured to beportable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump system 10 on the user's skin (e.g.,skin adhesive) underneath the user's clothing or carry the pump device100 in the user's pocket (or other portable location) while receivingthe medicine dispensed from the pump device 100. As described in moredetail below, the drive system may be housed in the housing structure110 of the pump device 100 in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 6 cm to about 7 cm (about6.4 cm in this embodiment), the overall length of the pump housingstructure 110 (which contains medicine cartridge and the drive system)can be about 7 cm to about 9 cm (about 8.3 cm or less in thisembodiment). In addition, the pump housing structure 110 may have anoverall height of about 1.5 cm to about 4 cm (about 2.9 cm or less inthis embodiment) and an overall thickness of about 8 mm to about 20 mm(about 14.5 mm or less in this embodiment). In such circumstances, thecontroller device 200 can be figured to mate with the compact pumphousing 110 so that, when removably attached to one another, thecomponents define a portable infusion pump unit that stores a relativelylarge quantity of medicine compared to the overall size of the unit. Forexample, in this embodiment, the infusion pump system 10 (including thepump device 100 attached to the removable controller device 200) mayhave an overall length of about 7 cm to about 9 cm (about 8.5 cm or lessin this embodiment), an overall height of about 1.5 cm to about 4 cm(about 3.5 cm or less in this embodiment), and an overall thickness ofabout 8 mm to about 20 mm (about 15 mm or less in this embodiment).

As shown in FIG. 3, this embodiment of the infusion pump system 10 ispocket-sized so that the pump device 100 and controller device 200 canbe worn in the user's pocket or in another portion of the user'sclothing. In such embodiments, the cap member 115 of the pump device 100may be configured to connect with a flexible tube 119 of an infusionset. The infusion set may include the tube 119 that extends toward askin adhesive patch and connects with an infusion cannula (not shown inFIG. 3). The skin adhesive patch can retain the infusion cannula influid communication with the tissue or vasculature of the patient sothat the medicine dispensed through the tube 119 passes through thecannula and into the user's body. As described below in connection withFIG. 5, the cap member 115 may provide fluid communication between theoutput end 122 (FIG. 1) of the medicine cartridge 120 and the tube 119of the infusion set. In these embodiments, the user can carry theportable infusion pump system 10 (e.g., in the user's pocket, connectedto a belt clip, or adhered to the user's skin) while the tube 119extends to the location in which the skin is penetrated for infusion. Ifthe user desires to monitor the operation of the pump device 100 or toadjust the settings of the infusion pump system 10, the user can readilyaccess the user interface 220 of the controller device 200 without theneed for carrying and operating a separate module.

In other embodiments, the infusion pump system 10 may be configured toadhere to the user's skin directly at the location in which the skin ispenetrated for medicine infusion. For example, a rear surface 102 of thepump device 100 (refer, for example, to FIG. 2) may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capmember 115 may have a configuration in which medicine passes directlyfrom the cap member 115 into an infusion cannula that is penetrated intothe user's skin. Again, if the user desires to monitor the operation ofthe pump device 100 or to adjust the settings of the infusion pumpsystem 10, the user can readily access the user interface 220 of thecontroller device 200 without the need for carrying and operating asecond, separate device. For example, the user may look toward the pumpdevice 100 to view the user interface 220 of the controller device 220that is removably attached thereto.

Referring to FIG. 4, some embodiments of an infusion pump system 20 mayinclude a pump device 100 that is configured to mate with any one of twoor more controller devices (e.g., controller device 200 and controllerdevice 300 in this embodiment) that are different from one another. Thecontroller devices 200 and 300 may have different user interfaces 220and 320, respectively, so as to provide different control options to theuser. For example, some users may select the first controller device 200for use in combination with the pump device 100 for a simplified inputcomprising two buttons 224 a and 224 b in the user interface 220. Inanother example, some users may select the second controller device 300for use in combination with the pump device 100 for a larger sizedisplay 322 and increased button options (e.g., four buttons 324 a, 324b, 324 c, and 324 d) in the user interface 320.

The pump device 100 can be releasably secured to any one of thecontroller devices 200 and 300 in the infusion pump system 20. Aspreviously described, the pump device 100 includes a pump housingstructure 110, and at least a portion of the pump housing structure 110is configured to be received in a complementary cavity 215 or 315 (FIGS.8-10) defined in the controller housing structure 210 or 310. When thepump device 100 is received by the controller device 200 or 300, aretainer finger 217 or 317, respectively, may engage a mating surface ofthe pump housing structure 110. In addition, a magnetic attachment canbe used to releasably secure the pump device 100 to any of thecontroller housing structures 210 and 310. In such circumstances, thepump device 100 includes one or more magnetically attractable devices118 a and 118 b (e.g., permanent magnets in this embodiment) exhibitedon the front surface 104 of the pump housing structure 110 whichmagnetically engage complementary devices (refer, for example to FIG. 8)arranged on the controller housing structure 210 or 310. As such, whenthe pump device 100 is received in the cavity defined by the controllerhousing structure 210, the magnetically attractable devices 118 a and118 b form a magnetic attachment to retain the pump device 100 therein.Also as described in more detail below, the pump device 100 may includeone or more electrical contacts 149 arranged to engage complementaryelectrical contacts 249 (refer, for example to FIG. 8) arranged on thecontroller housing structure 210 or 310.

In some embodiments of the infusion pump system 20, the first and secondcontroller devices 200 and 300 may be configured to control thedispensation of the same type of medicine when the pump device 100 isremovably attached thereto. For example, a medicine cartridge containinginsulin may be received in the pump device 100, and the user may select(e.g., based upon the user's preference, based upon an expert'srecommendation, or a combination thereof) either the first controllerdevice 200 or the second controller device 300 for attachment to thepump device 100. Because the first controller device 200 includes a userinterface 220 that is different from the user interface 320 of thesecond controller device 300, the user may prefer the operation,appearance, or functionality of one controller device (200 or 300) overthe other (300 or 200). For example, some users may select the firstcontroller device 200 to provide a simplified input comprising twobuttons 224 a and 224 b in the user interface 220 (e.g., lowercomplexity of input options may be preferable to child users). Inanother example, some users may select the second controller device 300to provide a larger size display 322 and increased button options 324 a,324 b, 324 c, and 324 d in the user interface 320 (e.g., increased inputoptions may be preferably to users who frequently monitor a number ofpump settings and summary screens). Alternatively, the controllerdevices 200 and 300 may include the same user interface option, but mayhave different appearances so as to provide the user with a variety ofstyles. For example, the controller device 200 may have a differentouter shape or a different color than that of the second controllerdevice 300, thereby permitting the user to select one of the controllerdevices 200 or 300 depending upon the desired appearance of the infusionpump system 20.

Still referring to FIG. 4, in some embodiments of the infusion pumpsystem 20, the first and second controller devices 200 and 300 may beconfigured to control the dispensation of the different types ofmedicine when the pump device 100 is removably attached thereto. Forexample, a first medicine cartridge 230 containing a first type ofmedicine 231 can be received in the pump device 100. In thesecircumstances, the first controller device 200 may be removably attachedto the pump device 100 (having the first medicine container 230 receivedtherein) so as to control the dispensation of the first type of medicine231. In another example, a second medicine cartridge 330 containing asecond type of medicine 331 can be received in the pump device 100.Here, the second controller device 300 may be removably attached to thepump device 100 (having the second medicine container 330 receivedtherein) so as to control the dispensation of the second type ofmedicine 331. Accordingly, the infusion pump system 20 can employ asingle pump device 100 that is capable of dispensing any one of two ormore medicines (e.g., medicines 231 and 331 in this embodiment) whenconnected to any one of two or more controller devices (e.g., controllerdevices 200 and 330, respectively, in this embodiment).

Such embodiments of the infusion pump device 20 permit a user totransition from the infusion of one type of medicine to a second type ofmedicine without learning to operate a new type of pump device. In oneembodiment, the pump device 100 may be used in combination with thefirst controller device 200 so as to deliver a medicine 231 for thetreatment of Type 2 Diabetes. Examples of such medicines 231 includeExenatide, which is commercially available under the name BYETTA™, orothers in a class of medicines for Type 2 Diabetes called incretinmimetics. These medicines may improve control of Type 2 Diabetes byaiding the user's pancreas produce an appropriate amount of insulin. Asdescribed in more detail below in connection with FIGS. 5A-D, the secondcontroller device 200 may include a user interface 220 configured toprovide information and monitoring options for the infusion ofExenatide.

If the user's Diabetes progresses over time to become Type 1 Diabetes,the user may continue to use the same type of pump device 100 but with adifferent controller device 300 (e.g., a controller device for use inthe infusion of insulin or other medicines to treat Type 1 Diabetes).Thus, the user is not required to obtain and learn about a new type ofpump device 100. Instead, the user may conveniently attach the same typeof pump device 100 (this time including a cartridge 330 with insulin331) to a second controller device 300. As described in more detailbelow in connection with FIGS. 6A-D, the second controller device 300may include a user interface 320 configured to provide information andmonitoring options for the infusion of insulin. In some circumstances,the dispensation rate, dosage amount, and other parameters of insulininfusion may be different from other infused medicines (e.g.,Exenatide), so the user interface 320 may provide different monitoringoptions or different textual information compared to the user interface220 of the first controller device 200.

Moreover, such embodiments of the infusion pump system 20 may providemanufacturing benefits. For example, the manufacturer may not berequired to manufacture a different type of pump device 100 for each ofthe different types of controllers. Instead, the pump device 100 can bemass produced in high quantities for use in conjunction with any one ofa plurality of controller devices (e.g., controller devices 200 and 300in this embodiment).

Optionally, the first controller device 200 may include an indicia 225that identifies the particular type of medicine cartridge 230 ormedicine 231 with which it is to be employed. The medicine cartridge 230may include a similar indicia 235. As such, the user can verify that theappropriate type of medicine 231 is received in the pump device 100 forcontrolled dispensation by the controller device 200. For example, theindicia 225 may include a label, marking, etching, or the like disposedon the controller housing structure 210 that indicates a particularname, code, or other identifier corresponding to a particular medicine231 (e.g., “EXENATIDE” or “BYETTA” or another identifier). The indicia235 disposed on the medicine cartridge 230 may include a similar label,marking, etching, or the like disposed on an outer surface of thecartridge 230 so as to indicate a particular name, code, or otheridentifier corresponding to the particular medicine 231. The secondcontroller device 300 may also include an indicia 325 that identifiesthe particular type of medicine cartridge 330 or medicine 331 with whichit is to be employed (e.g., “INSULIN” or another identifier). Theindicia 325 may match a corresponding indicia 335 arranged on themedicine cartridge 330. Thus, a person or machine will be able tointerpret the indicia 235 on the first cartridge 230 and the indicia 225on the first controller device 220 to know that the first cartridge 230is used in conjunction with the first controller device 200. Similarly,a person or machine will be able to interpret the indicia 335 on thesecond cartridge 230 and the indicia 325 on the second controller device320 to know that the second cartridge 330 is used in conjunction withthe second controller device 300.

Referring to FIGS. 5A-D, in some embodiments, the user interface 220 ofthe first controller device 200 may be configured to provide informationand monitoring options for the infusion of a first type of medicine,such as Exenatide. In this embodiment, the user interface 220 comprisesa display and two buttons as previously described in connection withFIGS. 1-4. The user may press one or more buttons of the user interface220 to toggle through a number of monitoring screens that provideinformation regarding the dispensation of the Exenatide medicine orregarding the operation of the pump device. For example, as shown inFIGS. 5A-D, the user interface 220 may provide information regarding theaverage amount of Exenatide infused per day (FIG. 5A), regarding thetotal amount of Exenatide infused on the current day and the averagedispensation rate of the pump device on the current day (FIG. 5B),regarding the amount of Exenatide remaining in the medicine cartridgereceived in the pump device 100 (FIG. 5C), and regarding the amount oftime since the pump device 100 started dispensing Exenatide (FIG. 5D).In some circumstances, the user may be able to press one or more buttonsof the user interface 220 (e.g., press both buttons at the same time,press and hold one button for a period of time, or the like) so as toadjust particular settings of the infusion pump system. For example, theuser may press and hold both buttons when a particular screen isdisplayed so as to adjust the dispensation rate, to adjust the time ordate, or to reset the average dispensation calculation.

Referring to FIGS. 6A-D, in some embodiments, the user interface 320 ofthe second controller device 300 may be configured to provideinformation and monitoring options for the infusion of a second type ofmedicine, such as insulin. In this embodiment, the user interface 320comprises a display and four buttons as previously described inconnection with FIG. 4. The user may press one or more buttons of theuser interface 320 to toggle through a number of monitoring screens thatprovide information regarding the dispensation of the insulin medicineor regarding the operation of the pump device 100. For example, as shownin FIGS. 6A-D, the user interface 320 may provide information regardingthe average amount of insulin infused per day (FIG. 6A), regarding thetotal amount of insulin infused on the current day and the averagedispensation rate of the pump device on the current day (FIG. 6B),regarding the amount of insulin remaining in the medicine cartridgereceived in the pump device 100 (FIG. 6C), and regarding the amount oftime since the pump device 100 started dispensing insulin (FIG. 6D). Insome circumstances, the user may be able to press the menu and selectbuttons button of the user interface 320 so as to toggle to a parameteradjustment screen, in which the “−” or “+” buttons may be used to adjustthe values. For example, the user may adjust the dispensation rate, toadjust the time or date, or to reset the average dispensationcalculation.

Referring now to FIG. 7, the pump device 100 of the infusion pump system10 or 20 may include a drive system 105 that is controlled by theremovable controller device 200 or 300. Accordingly, the drive system105 can accurately and incrementally dispense fluid from the pump device100 in a controlled manner. In this embodiment, the pump housingstructure 110 includes a detachable shell 112 that covers at least aportion of the drive system 105 and includes a frame portion 113 towhich at least a portion of the drive system 105 is mounted. Thedetachable shell 112 may include an inner curved surface against which acurved section of a piston rod 170 rests. The detachable shell 112 canbe part of the pump housing structure 110 that engages with thecontroller device 200 (or 300) as previously described in connectionwith FIGS. 1-4. As such, the detachable shell portion 112 may includethe magnetically attractable devices 118 a and 118 b that releasablysecure the pump device 100 to the controller device 200 (or 300). Inaddition, the detachable shell 112 may provide access to the electricalcontacts 149 a of the pump device 100. In this embodiment, theelectrical contacts 149 a are configured to align with the contactcircuit device 149 b arranged in the pump device 100. In otherembodiments, the electrical contacts of the pump device 100 can bearranged directly on the contact circuit device 149 b, and thedetachable shell 112 may include a slot (in the location shown asnumeral 149 a) so as to permit electrical engagement with the controllerdevice 200 (or 300).

One or both of the detachable shell 112 and the frame portion 114 can bemolded from polymer material, such as Polycarbonate, AcrylonitrileButadiene Styrene, or Acrylic. In this embodiment, the detachable shellportion 112 comprises a generally opaque, moldable material so that thedrive system 105 and other components of the pump device are concealedfrom view. The frame portion 113 may include a cylindrical receiver 114that defines the space 116 to receive the medicine cartridge 120 (FIG.2). In some circumstances, at least a portion of the cylindricalreceiver 114 is transparent or translucent so that the user may view themedicine cartridge 120 therein. Such a configuration provides the userwith visual verification of when the medicine cartridge is empty or nearempty (e.g., the plunger in the medicine cartridge has been fullyadvanced).

The receiver 114 may also include a connector to mate with the capmember 115. In this embodiment, the connector comprises an externalthread pattern formed on the receiver 113 that mates with an internalthread pattern of the cap member 115. Accordingly, the cap member 115can be secured to the frame portion 113 after the medicine cartridge 120(FIG. 2) has been received therein. As shown in FIG. 7, the cap membermay include a cartridge penetrator 115 a that pierces the output end 122(FIG. 2) of the medicine cartridge 120 when the cap member 115 ismounted to the frame portion 113. The cartridge penetrator 115 a is influid communication with an tube connector 115 b, which is connected toa tube 119 of an infusion set device (as previously described inconnection with FIG. 3). As previously described, in some embodiments,the fluid cartridge 120 may occupy a majority of the length of the pumphousing structure 110 (with the drive system 105 being arranged in acompact manner) so that the pump device 100 is wearable and portable.

Still referring to FIG. 7, some embodiments of the pump device 100include a first battery 145 that is capable of transmitting electricalenergy to the controller device 200 (or 300) when the pump device 100 isattached to the controller device 200 (or 300). Such energy transmissionis described in more detail below in connection with FIG. 8. The firstbattery 145 may be arranged in a first circuit 140 that includes thecontact circuit device 149 b. The first circuit 140 may be simple andinexpensive so as to facilitate a low-cost pump device 100 that isdisposable. The first circuit 140 may comprise a printed circuit boardor a flexible circuit that is arranged in the frame portion 113 of thepump device 100. Optionally, the first circuit 140 may include a gatewaycircuit device 146 that permits the transmission of electrical energyfrom the first battery 145 to the controller device 200 (or 300). Insome circumstances, the gateway circuit device 146 may be under thecontrol of and directed by the control circuit in the controller device200 (or 300). In some embodiments, the gateway circuit device 146 of thefirst circuit 140 may be in electrical communication (e.g., via one ormore electrical wires or electrically conductive traces) with a forcesensor 148 (refer to FIG. 11) arranged between the plunger connector 178that the plunger 121. The force sensor 148 may comprise a forcetransducer or load cell that is capable of electrically communicating anapplied force. As such, the force sensor 148 can provide feedbacksignals to the local pump circuit 140 (or to the control device 200 viathe electrical contacts) so as to monitor the force transmitted to theplunger 121 of the medicine cartridge 120. Such information can be used,for example, to detect if an occlusion exists in the medicine flow path.Other sensors (e.g., a pressure sensor, a flow sensor, a rotationsensor, a displacement sensor, or the like) may be electricallyconnected to the first circuit 140 to provide feedback signals to thecontrol device 200 via the electrical contacts. It should be understoodthat, in other embodiments, the first circuit 140 may be configured tooperate without the gateway circuit device 146. For example, the controlcircuit in the removable controller device 200 may communicate via theelectrical contacts directly with a portion of the drive system 105(e.g., direct electrical communication with the motor 130), with one ormore sensors disposed in the pump device 100 (e.g., with the forcesensor 148), and with the first battery 145.

In this embodiment, the first battery 145 can be maintained in a storagemode and then switched to an activation mode when the pump device 100used to dispense medicine. The storage mode can provide a long shelflife of storage life for the first battery 145. For example, when instorage mode, the first battery may retain a substantial portion of itscharge for a period of more than six months, more than one year, or morethan two years. As shown in FIG. 7, the first battery 145 may beequipped with a removable tab 147 that seals the first battery 145 tomaintain it in the storage mode. Thus, when the pump device 100 isprepared for usage, the removable tab 147 can be pulled away from thefirst battery 145, which switches the first battery into the activationmode. When the first battery 145 is switched to the activation mode, thefirst battery 145 may dispense electrical energy for usage period inwhich the pump device is used. For example, in some embodiments, thefirst battery 145 may provide electrical energy to other components overa usage period of about one week to about one month, and about two weeksin this embodiment.

As shown in FIG. 7, some embodiments of the drive system 105 may includea rotational motor 130 that is coupled to a string member 135, which isused to adjust a ratchet mechanism 150. The operation of the drivesystem 105 is described in more detail below in connection with FIGS.12A-C. The drive system 105 can provide a reliable and compactconfiguration for accurately dispensing the desired volume of fluid fromthe pump device 100. Moreover, the drive system 105 may comprise few, ifany, high-cost actuator components or electronics, thereby facilitatingthe relatively low-cost production of a disposable and reliable pumpdevice 100.

Referring to FIG. 8, the controller device 200 can be attached to thepump device 100 in a removable manner. In this embodiment, the housingstructure 210 of the controller device 200 defines a cavity 215 in whichat least a portion of the pump device 100 can be received (refer, forexample, to FIG. 2). When the pump device 100 is received in the cavity215, the finger 212 of the controller housing structure 212 may engage amating surface 117 (FIG. 2) of the pump device 100. In addition, thecontroller device 200 can include magnetically attractable devices 218a-b that align with the magnetically attractable devices 118 a-b (FIG.7) of the pump device 100. As such, the magnetically attractable devices118 a-b and 218 a-b releasably secure the pump device 100 in the cavity215 of the controller device 200. In some embodiments, both the devices118 a-b and 218 a-b may comprise permanent magnets. In otherembodiments, one set of the devices 118 a-b or 218 a-b may comprisepermanent magnets while the opposing set of the devices 218 a-b or 118a-b comprise a metallic material that is attractable to the permanentmagnets.

The controller device 200 can also include one or more electricalcontacts 249 that provide electrical communication to a controllercircuit 240. In this embodiment, the electrical contacts 249 arearranged on the controller housing structure 210 so as to align with theelectrical contacts 149 a (or the electrical contact device 149 b) ofthe pump device 100 (refer, for example, to FIG. 7). Accordingly, whenthe pump device 100 is removably attached to the controller device 200,the controller device 200 becomes electrically connected to the pumpdevice 100 to provide for the communication of electrical controlsignals.

Still referring to FIG. 8, the controller circuit 240 of the controllerdevice 200 may include a second battery 245 that can receive electricalenergy from the first battery 145 (FIG. 7) disposed in the pump device100. The hard-wired transmission of the electrical energy can occurthrough the electrical contacts 249 of the controller device 200. Insuch circumstances, the first battery 145 may include a high densitybattery that is capable providing a relatively large amount ofelectrical energy for its package size. Accordingly, the first battery145 disposed in the pump device 100 can be used to deliver electricalenergy over time (e.g., “trickle charge”) to the second battery 245 whenthe controller device 200 is removably attached to the pump device 100.For example, the first battery 145 may comprise a zinc-air cell battery.The zinc-air cell battery 145 may have a large volumetric energy densitycompared to some other battery types. For example, the zinc-air cellbattery 145 may have a volumetric energy density of greater than about900 Watt-hours/Liter (Wh/L), about 1000 Wh/L to about 1700 Wh/L, andabout 1200 Wh/L to about 1600 Wh/L. Also, the zinc-air cell battery mayhave long storage lives, especially in those embodiments in which thebattery is sealed (e.g., by the removable tab 147 or the like) duringstorage and before activation. One exemplary a zinc-air cell battery isavailable from Duracell Corporation of Bethel, Conn., which provides apotential voltage of about 1.1V to about 1.6V (about 1.2V to about 1.4V, and about 1.3 V in this embodiment), a current output of about 8 mAto about 12 mA (about 10 mA in this embodiment), and a storage capacityof greater than about 600 mA·h (about 650 mA·h in this embodiment).

The second battery 245 may include a high current output device that iscapable discharging a brief current burst to power the drive system 105of the pump device 100. Accordingly, the second battery 245 can becharged over a period of time by the first battery 145 and thenintermittently deliver high-current bursts to the drive system 105 overa brief moment of time. For example, the second battery 245 may comprisea lithium polymer battery. The lithium polymer battery disposed in thecontroller device 200 may have an initial current output that is greaterthan the zinc-air cell battery disposed in the pump device 100, butzinc-air cell battery may have an energy density that is greater thanthe lithium polymer battery (e.g., the lithium polymer battery disposedin the controller device 200 may have a volumetric energy density ofless than about 600 Wh/L). In addition, the lithium polymer battery isrechargeable, which permits the zinc-air battery disposed in the pumpdevice 100 to provide electrical energy to the lithium polymer battery245 for purposes of recharging. One exemplary lithium polymer battery isavailable from Sanyo Corporation of Japan, which provides a initialcurrent output of about greater than 80 mA (about 90 mA to about 110 mA,and about 100 mA in this embodiment) and a maximum potential voltage ofabout 4.0V to and 4.4V (about 4.2 V in this embodiment). In otherembodiments, it should be understood that the second battery 245 maycomprise a capacitor device capable of recharging over time andintermittently discharging a current burst to activate the drive system105.

Because the controller device 200 can be reusable with a number of pumpdevices 100 (e.g., attach a new pump device 100 after the previous pumpdevice 100 is expended and disposed), the second battery 245 in thecontroller device can be recharged over a period of time each time a newpump device 100 is connected thereto. Such a configuration can beadvantageous in those embodiments in which the pump device 100 isconfigured to be a disposable, one-time-use device that attaches to areusable controller device 200. For example, in those embodiments, the“disposable” pump devices 100 recharge the second battery 245 in the“reusable” controller device 200, thereby reducing or possiblyeliminating the need for separate recharging of the controller device200 via a power cord plugged into a wall outlet.

The controller circuit 240 of the control device 200 includes amicrocontroller device 246 that coordinates the electrical communicationto and from the controller device 200. At least a portion of thecontroller circuit 240 can be embodied on a printed circuit board (or aflexible circuit substrate). The second battery 245 and themicrocontroller 246 can be mounted to such a printed circuit board (orconnect to such a flexible circuit substrate). Electrical connectionsfrom the electrical contacts 249 and the user interface 220 (FIG. 9) mayextend along the printed circuit board to the microcontroller device246. In this embodiment, the controller circuit 240 is disposed in ahollow space of the controller housing structure 210. For example, thecontroller housing structure can be formed from two molded portions thatare welded or adhered to one another after the controller circuit 240 isassembled therein.

As shown in FIG. 8, some embodiments of the controller circuit 240 mayinclude a cable connector 243 (e.g., a USB connection port or anotherdata cable port). As such, a cable may be connected to the controllercircuit 240 to upload data or program settings to the controller circuitor to download data from the controller circuit 240. For example,historical data of medicine delivery can be downloaded from thecontroller circuit 240 (via the cable connector 243) to a computersystem of a physician or a user for purposes of analysis and programadjustments. Optionally, the data cable may also provide rechargingpower to the controller circuit 240.

Referring to FIG. 9, the user interface 220 of the controller device 200can include input components, output components, or both that areelectrically connected to the controller circuit 240 (FIG. 8). Forexample, in this embodiment, the user interface includes a displaydevice 222 having an active area 223 that outputs information to a userand two buttons 224 a and 224 b that receive input from the user. Here,the display 222 may be used to communicate a number of settings or menuoptions for the infusion pump system 10. In this embodiment, thecontroller circuit 240 may receive the input commands from the user'sbutton selection and thereby cause the display device 222 to output anumber of menus or program screens that show particular settings anddata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining the cartridge 120, or thelike). As previously described, the controller circuit 240 can beprogrammable in that the input commands from the button selections cancause the controller circuit 240 to change any one of a number ofsettings for the infusion pump system 100.

Referring to FIGS. 9 and 10, the first controller device 200 has a userinterface 220 that is different from the user interface 320 of thesecond controller device 300 so as to provide different control options.In the depicted embodiments, the first controller device 200 provides asimplified input comprising two buttons 224 a and 224 b in the userinterface 220, and the second controller device 300 provides a largersize display 322 and increased button options (e.g., four buttons 324 a,324 b, 324 c, and 324 d). As previously described, both controllerdevices 200 and 300 can be used to control the dispensation of medicinefrom the pump device 100. It should be understood from the descriptionherein that the second controller device 300 can include a controllercircuit that is similar to the controller circuit 240 (FIG. 8) of thefirst controller device 200. Accordingly, some embodiments of the secondcontroller device 300 may include a second battery (to provide bursts ofcurrent to power the drive system 105 of the pump device 100),electrical contacts (to align with the contacts 149 a or the contactdevice 149 b of the pump device 100), and a microcontroller device. Inaddition, it should be understood from the description herein that thesecond controller device 300 can include a cavity 315 that is similarlyshaped to the cavity 215 (FIG. 8) of the first controller device 200.Also, the second controller device 300 may include a finger 312,magnetically attractable devices, or both similar to the finger 212 anddevices 218 a-b depicted in FIG. 8.

Referring to FIG. 11, the pump device 100 includes a drive system 105that is capable of accurately and incrementally dispensing fluid fromthe fluid cartridge 120 in a controlled manner. The drive system 105 mayinclude a rotational motor 130 that is coupled to a string member 135.Briefly, the rotational motor 130 can be used to act upon the stringmember 135, thereby causing the string member 135 to adjust a pawlmember 152 relative to a ratchet body 155 (e.g., a ratchet wheelintegrally formed on the worm gear 156 in this embodiment). In someembodiments, the string member 135 is configured in a loop arrangement(e.g., looped around pin structures 136, 137, 138, and 139 in thisembodiment). In these circumstances, the motion path of the stringmember 140 and the orientation of the string member 140 can beconfigured to provide an efficient mechanical advantage orientationduring the desired motion of the adjustable pawl member 152. One of thepin structures 138 may be coupled to the adjustable pawl member 152while the remaining pin structures 136, 137, and 139 are coupled to theframe portion 114 of the pump device 100. The spring device 154 candrive the pawl member from a reset position to a forward position, whichincrementally rotates the ratchet wheel 155. As previously described,incremental rotation of the ratchet wheel 155 causes rotation of a drivewheel 160, which causes the incremental longitudinal advancement of aflexible piston rod 170. As the piston rod 170 is advanced into plungerchamber 126 (e.g., defined in this embodiment by the circumferentialwall 124 of the fluid cartridge 120), the fluid in the cartridge 120 isforced from septum at the output end 122. Previously incorporated U.S.Provisional Application Ser. No. 60/720,411 also describes a number ofconfigurations for the drive system in addition to the illustrativeexample depicted in FIG. 11 herein.

As shown in FIG. 11, some components of the drive system 105 can beretained by the frame portion 114, a cover mount 111 that is assembledto the frame portion 114, or a combination thereof. For example, therotational motor 130, the string member 135, and the spring device 154can be assembled into the frame portion 114 and then retained by thecover mount 111. The adjustable pawl member 152, the ratchet wheel 155,and the worm gear 156 can be assembled onto and axle 151 that isintegrally formed with the frame portion 114 and then retained by thecover mount 111. A locking pawl 159 can be integrally formed with theframe portion 114 so as to align with the ratchet wheel 155 when theratchet wheel 155 is assembled onto the axle 151. Also, the drive wheel160 and an adjacent bearing 165 (to facilitate rotation of the drivewheel 160 relative to the frame portion 114) can be received in annularchannels 163 and 167, respectively, of the frame portion 114. When thecover mount 111 is assembled to the frame portion 114, the cover mount111 can restrict the radial or axial movement of the drive wheel 160while permitting forward rotation of the drive wheel 160. In anotherexample, the “unused” or retracted portion of the piston rod 170 mayrest in a channel 113 defined in the top of the cover mount 111. In sucha construction, the cover mount 111 and the frame portion 114 cancollectively permit the desired motion of the components of the drivesystem 105 while reducing the likelihood of “backlash” movement orcomponent dislodgement (which might otherwise occur, for example, whenthe pump device 100 is dropped to the ground).

The rotational motor 130 may comprise an electrically power actuatorhaving a rotatable output shaft 132. In this embodiment, the rotationalmotor 130 can receive signals that cause the output shaft to rotate in afirst rotational direction or in a second, opposite rotationaldirection. One example of a suitable rotational motor 130 is a corelessDC motor supplied by Jinlong Machinery of China. As previouslydescribed, the operation of the rotational motor 130 can be controlledby a controller device (e.g., removable controller device 200 or 300 asdescribed in connection with FIGS. 1-10 or the like) via electricalsignals communicated through one or more electrical contacts.

The string member 135 may be coupled to the rotational motor 130 so thatactuation by the motor 130 causes the string member 135 to act upon theratchet mechanism 150. One or more full rotations of the motor 130 canbe translated into a tension force in the string member 135 that isapplied to a pawl member 152, which (in this embodiment) is pivoted to areset position by the tension force from the string member 135. As such,the string member 135 is coupled between the rotational motor 130 andthe ratchet mechanism 150 so as to provide a reliable and consistentadjustment of the ratchet mechanism. In this embodiment, the stringmember 135 is coupled to the motor shaft 132 using a mechanicalconnector 133.

Still referring to FIG. 11, the ratchet mechanism 150 includes the pawlmember 152 and the ratchet body 155, which in this embodiment is aratchet wheel having a number of teeth along its circumferentialsurface. The pawl member 152 is adjustable between a reset position(refer, for example, to FIG. 12A) and a forward position (refer, forexample, to FIG. 12B). In this embodiment, the adjustable pawl member152 is pivotably coupled to about the axis of the axle 151 that receivesthe ratchet wheel 155 and the worm gear 156. A spring device 154 is alsocoupled to the pawl member 152 so as to urge the pawl member 152 towardthe forward position. In this embodiment, the spring device 154 is inthe form of a leaf spring that is fixed to the frame portion 114 at afirst end portion and that is engaged with an abutment protrusion 157(FIGS. 12A-C) of the pawl member 152 at a second end portion. Thus, whenthe pawl member 152 is adjusted to the reset position, the spring device154 is flexed and stores potential energy that urges the pawl member 152to return to the forward position and thereby drive the ratchet wheel155 in a forward rotational direction. The locking pawl 159 coupled tothe frame portion 114 prevents the ratchet wheel 155 from reversemotion. As such, the adjustable pawl member 152 can adjust from theforward position to the reset position to engage a new tooth of theratchet wheel 155 while the ratchet wheel 155 remains in position due tothe locking pawl 159.

It should be understood that the drive system 105 can employ one or moresensors to indicate when the pawl member 152 has reach the resetposition or the forward position. For example, these sensors can beoptical, magnetic, or contact type sensors. The sensors may be capableof transmitting signals that indicate when the location of the pinstructure 138 or the pawl member 152 is detected. Such sensor signalsmay be transmitted to the first circuit 140, to the controller device200 or 300, or a combination thereof.

Still referring to FIG. 11, in some embodiments the ratchet wheel 155can be integrally formed with the worm gear 156 so that the incrementalrotation of the ratchet wheel 155 is translated to the worm gear 156.Such rotation of the worm gear 156 causes a rotation of a drive wheel160, which is rotatably mounted to the frame portion 114 of the pumpdevice 100. The drive wheel 160 includes a central aperture having aninternal thread pattern therein (not shown in FIG. 11), which mates isan external thread pattern on the flexible piston rod 170. Thus, theincremental motion provided by the ratchet mechanism 150, the stringmember 135, and the motor 130 causes the drive wheel 160 toincrementally rotate, which in turn translates to a linear advancementof the flexible piston rod 170.

Accordingly, in some embodiments, the piston rod 170 may undergo onlyforward or positive displacement as a result of drive system 105. Forexample, the drive system 105 substantially hinders the piston rod 170from retracting or “backing up” in response to fluid pressure in themedicine cartridge 120 or other reversal forces. In such circumstances,the flexible piston rod 170 can be retracted only upon disassembly ofthe pump device 100 (e.g., to disengage the gears or the ratchetmechanism). In those embodiments in which the pump device 100 isintended to be disposable, the non-retractable piston rod configuration(due to the drive system 105) may facilitate a “one time use” disposablepump device, thereby reducing the likelihood of failure due tonon-intended repeated use of the disposable pump device.

The flexible piston rod 170 comprises a plurality of segments 172serially connected by hinge portions so that the flexible piston rod 170is adjustable from a curved shape to a noncurved shape. As previouslydescribed, the plurality of segments 172 and the interconnecting hingeportions can be integrally formed in one piece from a moldable material,including one or more polymer materials such as Nylon or POM. In thisembodiment, the plurality of segments 172 comprise generally cylindricalsegments that each include an exterior thread pattern along at least onecylindrical surface portion. The flexible piston rod 170 can include ananti-rotation structure that hinders the piston rod 170 from rotatingwith drive wheel 160 (thereby allowing the rotation of the drive wheel160 to translate into a longitudinal motion of the piston rod 170). Forexample, in this embodiment, the flexible piston 170 includes alongitudinal channel 173 extending through each of the segments 172. Thelongitudinal channel 173 can engage a complementary protrusion on theframe portion 114 proximate the drive wheel 160 so that the flexiblepiston rod 170 is hindered from rotating when the drive wheel 160 turnsrelative to the frame portion 114. Accordingly, the longitudinal channelin each segment 172 aligns to form a keyway that receives a mating key(e.g., a protrusion) on the frame portion 114. In other embodiments, theanti-rotation structure may include a plurality of longitudinal channels173 (with each channel capable of engaging an associated protrusion thatacts as a key to hinder rotation while permitting longitudinal motion),one or more flat surfaces along each segment 172 (with the flat surfaceslidably engaging a complementary flat surface on the frame portion114), or the like. A plunger connector 178 may be coupled to the leadingend of the flexible piston rod 170 so as to abut against or connect withthe plunger 121 in the plunger chamber 126 of the fluid cartridge 120.Previously incorporated U.S. Provisional Application Ser. No. 60/720,405also describes a number of configurations for the flexible piston rod170 in addition to the configuration illustrated in FIG. 11 herein.

Referring now to FIGS. 12A-C, the incremental motion cycle of the drivesystem 105 may include rotation of the motor 130 so that the stringmember 135 transitions from a twisted state, to an untwisted state, andthen again to a twisted state. Such a transition of the string member135 can cause the pawl member 330 to adjust from the reset position(refer to FIG. 12A), to the forward position (refer to FIG. 12B), andback to the reset position (refer to FIG. 12C). The adjustment of thepawl member 152 from the reset position to the forward position drivesthe ratchet wheel 155 and worm gear 156, which incrementally rotates thedrive wheel 160 and thereby advances the flexible piston rod 170 alongitudinal increment distance 179 (refer to FIG. 12B). In one example,the drive system 105 can advance the piston rod 170 a longitudinalincrement distance 179 of about 16 microns or less (about 4 microns toabout 12 microns, and preferably about 7 microns to about 8 microns) foreach incremental motion cycle of the motor 130, string member 135, andratchet mechanism 150 as previously described herein.

Referring to FIG. 12A, in this embodiment of the incremental motioncycle, the pawl member 352 begins at the reset position with the stringmember 135 in a twisted configuration at string portion 134. When theadjustable pawl member 152 is in the reset position as shown in FIG.12A, it is capable of engaging a tooth of the ratchet wheel 155. In thisembodiment, the string member 135 is arranged in a loop configurationaround pin structures 136, 137, 138, and 139. One of the pin structures138 is coupled to the adjustable pawl member 152 while the remaining pinstructures 136, 137, and 139 are integrally formed with the frameportion 114 of the pump device 100 (pin structures 136, 137, and 139 areshown in dotted lines to represent their location on the frame portion114 (not shown in FIGS. 12A-C)). Also, the pin structure 136 exemplifieshow a single pin structure can have two sliding surfaces that oppose oneanother, thereby functioning similar to a configuration having twodifferent pins. As shown in FIG. 12A, when the motor 130 rotates, aportion 134 the string member 135 twists upon itself, thus drawing thepin structure 138 toward the stationary pin structures 137 and 139. Theorientation of the stationary pin structures 137 and 139 relative to thepin structure 138 (connected to the pawl member 152) can be configuredto provide an efficient mechanical advantage for the tension forceapplied by the string member 140 during the desired motion of theadjustable pawl member 152.

Referring to FIG. 12B, in response to the controller device 200 or 300transmitting one or more control signals to initiate the cycle, therotational motor 130 may begin to rotate in a first rotational directionthat unwinds the string member 140, thereby permitting the spring device154 to drive the pawl member 152 toward the forward position (refer toFIG. 12B). When the adjustable pawl 152 is driving the ratchet wheel 155in the forward rotational direction, the potential energy of the springdevice 154 is being translated to kinetic energy for the motion of thepawl member 152 and the ratchet wheel 155. Such an adjustment of thepawl member 152 from the reset position to the forward position drivesthe ratchet wheel 155 and the integrally formed worm gear 156. Theincremental rotation of the worm gear 156 results in an incrementalrotation by the drive wheel 160, which advances the flexible piston rod170 the longitudinal increment distance 179. Such an incrementaladvancement of the flexible piston rod 170 may cause a predeterminedvolume of fluid to be dispensed from the cartridge 120 (FIG. 11).

Referring to FIG. 12C, the rotational motor 130 continues to rotate inthe first rotational direction so that after the pawl member 152 reachesthe forward position, the string member 135 begins to twist in theopposite orientation. Such twisting of the string member 135 causes atension force that overcomes the bias of the spring device 154 andadjusts the pawl member 152 toward the reset position. When theadjustable pawl member 152 reaches the reset position, as shown in FIG.12C, the pawl member 152 is capable of engaging a new tooth of theratchet wheel 155. The locking pawl 159 (shown in FIG. 11) prevents theratchet wheel 155 from rotating in a reverse (non-forward) rotationaldirection while the adjustable pawl member 152 is shifting back to thereset position. Such an adjustment of the pawl member 152 back to thereset position causes the spring device 154 to flex (as shown in FIG.12C), thereby storing potential energy to drive the adjustable pawlmember 152 and ratchet wheel 155 in a subsequent cycle. After the pawlmember 152 reaches the reset position, the rotational motor 130 stopsrotating in the first rotational direction and the pawl member 152remains at rest in the reset position (refer to FIG. 12C). In the eventof a subsequent cycle, the rotational motor 130 would begin the cycle byrotating in a second rotational direction (opposite the first rotationaldirection) so as to unwind the string member 135 yet again. This patternof cycles may continue until the piston rod 170 has reached the limit ofits longitudinal travel.

It should be understood, that in other embodiments, the incrementalmotion cycle may begin with the pawl member 152 starting at the forwardposition (refer to FIG. 12B). In such circumstances, the rotation motor130 would rotate in a first rotational direction to twist the string 135until the pawl member 152 is moved to the reset position (refer to FIG.12C), and then the rotational motor 130 would rotate in a second,opposite rotational direction to unwind the string member 135 until thepawl member 152 returns to the forward position (refer again to FIG.12B).

The string member 135 may comprise braided filaments that are capable ofenduring repeated twisting sequences of the string member 135. Forexample, the braided filaments may comprise one or more polymermaterials, such as PET (e.g., DTex Dyneema material available fromHoneywell, Inc.). Such braided filament string members are capable ofenduring the torsion and frictional forces associated with undergoingthousands of cycles of twisting as described above in connection withFIGS. 12A-C. The string member 135 can be formed to have an outerdiameter of about 0.02 mm to about 0.07 mm, and preferably about 0.05mm. Also, in some embodiments, the string member 135 may comprisebraided filaments that are arranged around a centrally disposed thinwire filament (e.g., comprising a polymer material or a metallicmaterial) having a diameter of about 0.02 mm or less, which is alsocapable of enduring the repeated twisting sequences of the string member135. Such a construction may permit the outer filament surfaces tofrictionally engage one another during the twisting process while thefilament surfaces contacting the centrally disposed thin wire areexposed to a reduced friction load.

Referring now to FIG. 13, some embodiments of drive system 405 for thepump device can include a string member and a rotational motor like thepreviously described embodiments, except that the string member 435 isconfigured to wind (or unwind or both) around a spindle device 434. Sucha configuration may reduce the torsion and friction loads upon thestring member material while providing a tension force to adjust theratchet mechanism. Moreover, the spindle configuration may furtherreduce the space requirements for drive system 405 in the pump housing,thereby providing a reliable and compact infusion pump system that isportable and wearable by the user.

As shown in FIG. 10, the spindle device 434 can be coupled to arotational motor 430 so that the spindle device 434 rotates with themotor shaft. A string member 435 can be attached to the spindle device434 so that the string member 435 winds or unwinds around the spindledevice 434 in response to the rotation of the motor 430. It should beunderstood from the description herein that the string member 435 maycomprise braided filaments that are capable of enduring repeated windingsequences of the string member 435. The string member 435 is alsocoupled to the ratchet mechanism 450, which provides incremental motionto thereby advance the piston rod 470. The ratchet mechanism 450includes the pawl member 452 and the ratchet body 455, which in thisembodiment is a ratchet wheel having a number of teeth along itscircumferential surface. The pawl member 452 is adjustable between areset position and a forward position. For example, the rotational motor430 may be activated to rotate the spindle device 434 and thereby windthe string member 435 (as previously described), and the string member435 then applies a tension force that adjusts the pawl member 452 to thereset position. In the reset position, the pawl member 452 can engageone or more new teeth of the ratchet wheel 455. A spring device 454 isalso coupled to the pawl member 452 so as to urge the pawl member 452toward the forward position. This spring force causes the pawl member452 to drive the ratchet wheel 455 an incremental amount in a forwardrotational direction. Similar to the embodiments previously described inconnection with FIG. 12A, a locking pawl prevents the ratchet wheel 455from reverse motion. As such, the adjustable pawl member 452 can adjustfrom the forward position to the reset position to engage a new tooth ofthe ratchet wheel 455 while the ratchet wheel 455 remains in positiondue to the locking pawl 459.

Accordingly, in one incremental motion cycle, the pawl member 452 maystart at the reset position with the string member 435 wound around thespindle device 434. In response to the controller device 200 or 300(FIG. 4) transmitting one or more control signals to initiate the cycle,the rotational motor 430 may begin to rotate in a first rotationaldirection that unwinds the string member 435 from the spindle device434, thereby permitting the spring device 454 to force the pawl member452 toward the forward position. The rotational motor 430 continues torotate in the first rotational direction so that after the pawl member452 reaches the forward position, the string member 435 begins to windaround the spindle device 434 in the opposite orientation. Such windingof the string member 435 causes a tension force that overcomes the biasof the spring device 454 and adjusts the pawl member 452 toward thereset position. After the pawl member 452 reaches the reset position,the rotational motor 430 stops rotating in the first rotationaldirection and the pawl member 452 remains at rest in the reset position.In the event of a second cycle, the rotational motor 430 would begin thecycle by rotating in a second rotational direction (opposite the firstrotational direction) so as to unwind the string member 440 from thespindle device 442 yet again.

In other embodiments, the incremental motion cycle may begin with thepawl member 452 starting at the forward position. In such circumstances,the rotational motor 430 would rotate in a first rotational direction towind the string member 435 around the spindle device 434 until the pawlmember 452 is moved to the reset position (as shown in FIG. 10), andthen the rotational motor 430 would rotate in a second, oppositerotational direction to unwind the string member 435 from the spindledevice 434 until the pawl member 452 returns to the forward position.

It should be understood that the drive system 405 can be contained inthe housing structure 110 of the pump device 100 in a compact manner sothat the pump device 100 is portable, wearable, concealable, or acombination thereof. Similar to previously described embodiments, thepump device 100 can be part of an infusion pump system 10 or 20 in whichthe pump device 100 communicates with a controller device, including butnot limited to the removable controller device 200 or 300 described inconnection with FIGS. 1-10. The controller device 200 or 300 cancommunicate control signals to the drive system 405 or other componentsof the pump device so as to initiate or end the incremental motion cycleof the drive system 405.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. A medicinal fluid supply system comprising: a pump assemblycomprising: a pocket to receive a pre-filled medicinal fluid cartridgethat has an output port, and a mechanism to push upon a pre-filledmedicinal fluid cartridge when installed in the pocket to dispense themedicinal fluid out of the output port of the pre-filled medicinal fluidcartridge; and a controller assembly that removable attaches to the pumpassembly, the controller assembly producing a signal to cause themechanism to push upon the cartridge.
 2. The system of claim 1, whereinthe pump assembly is a one-time-use only device.
 3. The system of claim2, further comprising a pre-filled medicinal fluid cartridge insertableinto the pocket.
 4. The system of claim 3, wherein the pre-filledmedicinal fluid cartridge contains a fluid comprising insulin.
 5. Thesystem of claim 3, wherein the pre-filled medicinal fluid cartridgecomprises substantially rigid side walls.
 6. A medicinal fluid supplysystem comprising: a pump assembly comprising: a pocket to receive apre-filled medicinal fluid cartridge, and a pusher that increasinglyadvances in only one direction so as to cause medicinal fluid to bedispensed from the cartridge when installed in the pocket; and acontroller assembly that removably attaches to the pump assembly, thecontroller assembly producing a signal to cause the pusher to advance.7. The system of claim 6, wherein the pump assembly is a one-time-useonly device.
 8. The system of claim 6, wherein advancement of the pusheracts upon a surface the cartridge.
 9. The system of claim 6, furthercomprising a pre-filled medicinal fluid cartridge insertable into thepocket.
 10. The system of claim 9, wherein the pre-filled medicinalfluid cartridge contains a fluid comprising insulin.
 11. The system ofclaim 9, wherein the pre-filled medicinal fluid cartridge comprisessubstantially rigid side walls.
 12. The system of claim 6, wherein thepusher is increasingly advances substantially along a longitudinal axisof the pre-filled medicinal fluid cartridge.
 13. The system of claim 6,wherein the pusher comprises threads to engage threads of a rotatingmember, wherein rotation of the rotating member causes at least aportion of the pusher to longitudinally advance.
 14. The system of claim13, wherein the rotating member rotates in only one direction.
 15. Amedicinal fluid supply system comprising: a pump assembly comprising: apocket to receive a pre-filled medicinal fluid cartridge that has afirst end, and a mechanism to push upon the first end of a pre-filledmedicinal fluid cartridge when installed in the pocket to dispense themedicinal fluid out of a second opposite end of the pre-filled medicinalfluid cartridge; and a controller assembly that removable attaches tothe pump assembly, the controller assembly producing a signal to causethe mechanism of the pump assembly to push upon the first end.
 16. Thesystem of claim 15, wherein the pump assembly is a one-time-use onlydevice.
 17. The system of claim 15, further comprising a pre-filledmedicinal fluid cartridge insertable into the pocket.
 18. The system ofclaim 17, wherein the pre-filled medicinal fluid cartridge contains afluid comprising insulin.
 19. The system of claim 17, wherein each ofthe pre-filled medicinal fluid cartridges comprises a substantiallytubular portion with rigid side walls between the first and second ends,the substantially tubular portion defining a volume to contain at leasta portion of a pre-filled medicinal fluid.
 20. The system of claim 15,wherein the mechanism comprises threads that engage threads of arotating member, wherein rotation of the rotating member causes themechanism to increasingly push upon the first end.
 21. The system ofclaim 20, wherein the rotating member rotates in only one direction. 22.A kit for use in supplying a medicinal fluid, the kit comprising: aplurality of pump assemblies, each of the pump assemblies comprising: apocket to receive a pre-filled medicinal fluid cartridge that has afirst end, and a mechanism to push upon the first end of a pre-filledmedicinal fluid cartridge when installed in the pocket to dispense themedicinal fluid out of a second opposite end of the pre-filled medicinalfluid cartridge; and a controller assembly that is removable attachableto each of the pump assemblies in the plurality of pump assemblies, thecontroller assembly producing a signal to cause the mechanism to pushupon the first end of the pre-filled medicinal fluid cartridge.
 23. Thekit of claim 22, wherein each of the pump assemblies is a one-time-useonly device, and the controller assembly is a reusable device.
 24. Thekit of claim 22, wherein the pocket of each of the pump assembliescomprises a cylindrical wall to receive the pre-filled medicinal fluidcartridge.
 25. The kit of claim 24, each of the pump assemblies furthercomprising a cap device that engages the pocket to retain the pre-filledmedicinal fluid cartridge when installed in the pocket.
 26. The kit ofclaim 25, wherein the cap device comprises a penetrator that pierces thesecond opposite end of the pre-filled medicinal fluid cartridge wheninstalled in the pocket.
 27. The kit of claim 22, further comprising asupply of the pre-filled cartridges, the supply comprising onepre-filled cartridge for each one of the pump assemblies of the kit. 28.The kit of claim 22, wherein the controller assembly is removableattachable to one of the pump assemblies at a time.